The Applied Technical Services Family of Companies performs biocompatibility evaluations for medical devices in compliance with ISO 10993 testing standards.
ISO 10993 Testing
ISO 10993 Testing consists of biological evaluation and analysis of medical devices in adherence with standards established by the International Organization for Standardization. These standards outline a systematic approach to assess the potential risks posed by medical devices to biological systems, primarily focusing on their compatibility with the human body.
ISO 10993 covers a variety of testing and evaluation methods designed to analyze the biological safety of medical devices throughout their lifecycle, from initial development to post-market surveillance. These tests cover factors including cytotoxicity, genotoxicity, sensitization, irritation, and systemic toxicity to ensure medical devices can be used safely without causing adverse reactions in patients. By subjecting medical devices to rigorous testing protocols, manufacturers can identify potential risks early in the development process, leading to the production of safer and more reliable products.
Biocompatibility Testing at Applied Technical Services
The testing process typically involves both in vitro (laboratory-based) and in vivo assessments, depending on the nature of the device and its intended use. ATS’ highly trained biocompatibility testing experts consider material composition, manufacturing processes, and clinical application when conducting ISO 10993 tests, applying decades of experience to ensure the most accurate, reliable results. ISO 10993 testing is crucial to ensuring the safety and effectiveness of medical devices, helping to promote patient safety and minimize manufacturer liability.
Additional Chemical Analysis Services
Consisting of highly advanced laboratories staffed by industry-leading experts, the Applied Technical Services Chemical Analysis Department offers an expansive list of chemistry services for a variety of industries and disciplines. Some of our most commonly requested chemical analysis services include:
- CPSIA Testing Lab Services
- DSC Polymer Analysis
- Benzene Analysis
- AZO Dye Testing
- OES Materials Testing
- VOC Emissions Testing
- Phthalate Testing
- Thermal Analysis
- Melting Point Analysis
- Ion Chromatography Testing
- LECO Testing
- HPLC Analysis
Applied Technical Services
With over five decades of business experience, state-of-the-art laboratories and testing facilities, and proficient chemists, technicians, and testing experts, the Applied Technical Services Family of Companies is the premier choice for your business’ testing and analysis needs. Our excellent reputation shows our commitment to providing both exceptional customer service and impeccable service quality is unparalleled.
Give the proven ISO 10993 testing experts a call today at 1 (888) 287-5227 or submit a request form on this page for additional information.
